 "Zydus Lifesciences gets 3 observations from USFDA for Vadodara plant")
Zydus Lifesciences on Thursday said the US health regulator has issued three observations after inspecting its Jarod (Vadodara) based manufacturing facility.
The US Food and Drug Administration (USFDA) inspected the injectable facility from February 24 to March 10, 2022.
The inspection closed with three observations, the drug firm said in a regulatory filing.
"We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network," Zydus Lifesciences stated.
As per the US health regulator, an FDA Form 483 (observation) is issued to a firm's management at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of Food Drug and Cosmetic (FD&C) Act and related Act.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)